Protein characterization
Comprehensive analysis of your protein-based product
Do you need a customized protein characterization, which covers e.g. identification, quantification and sequencing of your biopharmaceutical product and its residual impurities?
Are you looking to analyze the Host Cell Proteins (HCPs) throughout your purification steps or in pre-clinical and clinical-stage batches?
With our mass spectromet...
Do you need a customized protein characterization, which covers e.g. identification, quantification and sequencing of your biopharmaceutical product and its residual impurities?
Are you looking to analyze the Host Cell Proteins (HCPs) throughout your purification steps or in pre-clinical and clinical-stage batches?
With our mass spectrometry-based analyses, you can…
- Choose the HCP ELISA with highest coverage of your drug and process HCPs
- Get the identity and quantity of all individual proteins in your samples, including residual HCPs
- Confirm your protein sequence and locate issues with stability, modifications, truncations
Alphalyse protein services are optimized for a wide range of protein-based biologics. With experience from thousands of analytical runs and more than 100 HCP projects, we are a world leading protein characterization CRO, with an established and validated workflow for all expression systems and all sample types.
The analyses can be customized to fit your specific protein product, with the aim to strengthen your process development and production throughout the project. You can choose and combine your preferred analysis package from the services below or send us your project description so we can design an analysis package that meets your needs.
We conduct all protein analyses according to the ICH Q6B guidelines – Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. All repetitive tasks are automated to ensure high reproducibility and fast reporting time.
